Abrams Royal Pharmacy Recalls Calcium Chloride Injection Due to Sterility Failures
Abrams Royal Pharmacy is recalling 1,100 vials of Calcium Chloride Preservative Free Sterile Injection because contract testing found sterility failures.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Abrams Royal Pharmacy is recalling 1,100 vials of Calcium Chloride Preservative Free Sterile Injection, 100 mg/ml, 10 ml vial, Rx only. The recall is being conducted because the firm's contract testing laboratory found sterility failures in the product.
The affected product is identified by Lot # 05152013@4 (also written as 051513-4) with an expiration date of 11/11/13. The product was distributed to two hospitals in Dallas, TX.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
- Manufacturer
- Abrams Royal Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 05152013@4 (also written as 051513-4)
- Exp 11/11/13
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Abrams Royal Pharmacy
See all →- CriticalAbrams Royal Pharmacy Recalls Non-Sterile Lidocaine and Bupivacaine Syringes
FDA (Drugs) · 2014-11-26
- CriticalAbrams Royal Pharmacy Recalls Trace Mineral-5 MDV Due to Non-Sterility
FDA (Drugs) · 2014-11-26
Same hazard · non sterility
See all →- SevereChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
FDA (Drugs) · 2026-07-01
- SevereLSL Healthcare Infant Central Line Dressing Change Kit Recalled
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility
FDA (Devices) · 2026-04-29
Similar recalls
- HighCalcium Chloride Injectable Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-20
- SevereAxia Pharmaceutical Recalls Calcium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- SevereDowning Labs Recalls Potassium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereAbrams Royal Pharmacy Recalls All Unexpired Sterile Drug Products
FDA (Drugs) · 2014-09-03
- SevereCantrell Drug Recalls Calcium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2016-12-21
- SevereCalcium Chloride Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-22